Status:
TERMINATED
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
Lead Sponsor:
Ferris State University
Collaborating Sponsors:
Retina Specialists of Michigan
Conditions:
Moderate Non-proliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the role of alpha lipoic acid in patients who have moderate non-proliferative diabetic retinopathy. The primary aim of this study is to test the hypothesis th...
Detailed Description
Increased production of free radicals and depletion of antioxidants are commonly observed in diabetic patients. Based on animal studies, increased production of free radicals tends to persist even aft...
Eligibility Criteria
Inclusion
- Individual with diabetes mellitus type I or type II mild to moderate non-proliferative diabetic retinopathy which will be based on ETDRS grading scale
- Patient must be 18 years and older
Exclusion
- Patients with severe non-proliferative or proliferative diabetic retinopathy
- Patients with macular edema
- Eye diseases that may interfere with visualization of the fundus such as preretinal hemorrhage, cataract, vitreous hemorrhage
- Patient that has undergone any type of interventional therapy for diabetic retinopathy (Such as laser photocoagulation, vitrectomy)
- Amblyopia
- Glaucoma
- Patient with cataract surgery within a period of 4 months
- Patients with other retinal diseases
- Patients on chronic administration of alpha lipoic acid
- Known intolerance/hypersensitivity to alpha lipoic acid
- Patient with history of dialysis in cases of renal insufficiency and history of kidney transplantation
- Malignancies or life threatening diseases as determined by the investigators
- Current history of drug or alcohol abuse
- Pregnant and breast feeding women
- Cognitively impaired patients
- Participation in a clinical trial within the last 30 days
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01880372
Start Date
September 1 2013
End Date
April 1 2016
Last Update
February 15 2019
Active Locations (2)
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1
Ferris State University
Big Rapids, Michigan, United States, 49307
2
Retina Specialists of Michigan
Grand Rapids, Michigan, United States, 49525